EU Sets Benchmarks for Clinical Evidence Assessment for Recertification of Medical Devices
As a result of the new EU Medical Device Regulations (MDR), existing products (most legacy devices) that already had received CE Mark under the previous Medical Devices Directive (MDD), will need to be re-certified.
An Overview of Digital Health in China
We recently discussed the challenges and opportunities for diagnostic players amidst and post- the COVID-19 chaos in the context of China’s health care system. In this issue, we will discuss another industry sector that may benefit from this global pandemic, digital health.
FDA Releases Final Guidance on Oncology Therapeutic Class Labeling of Companion Diagnostics
The Food and Drug Administration recently published final guidance entitled “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products,” in which the FDA lists several key considerations for companion diagnostic manufacturers.
The VALID and VITAL Acts: What Do They Mean for Diagnostic Innovators?
At its core, the VALID Act would explicitly grant the FDA authority to regulate LDTs through a risk-based framework that categorizes LDTs as high risk or low risk, with high-risk tests facing approval requirements that are comparable to existing medical device regulations.
Infectious Disease Management in China and the Regulatory Mechanism for Clinical Diagnostics
COVID-19 is on the verge of becoming a pandemic. Here we highlight Chinese infectious disease management and the regulatory mechanism for clinical diagnostics.
German Draft Executive Order Provides Clarity for Reimbursement of Health Apps
The introduced reimbursement of digital health apps in Germany provides many chances for manufacturers of innovative digital health solutions.
Webinars and Digital Events
Publications
BHA Presents Study Results at the National Kidney Foundation Spring Clinical Meeting
April 2021
Dr. Datar and colleagues used conjoint analysis to estimate preferences regarding kidney disease testing from 401 PCPs via a web survey. Hypothetical patient profiles created using clinical parameters demonstrated the clinical utility of a novel kidney diagnostic used to risk-stratify patients based on the risk of kidney function decline. Read the article here.
BHA Partners with Alcon to Conduct Real-World Study Highlighting Efficiencies of Optical Biometer in Cataract Surgery
December 2020
Alcon, a global leader in eye care, collaborated with Boston Healthcare to conduct a Time-and-Motion Study to support the value communication of its novel swept-source optical coherence tomography biometer, ARGOS®. The ISPOR abstract, titled, Time Efficiencies Associated with an Innovative Optical Biometer in Cataract Surgery Planning- A Time-and-Motion Study, can be found here, and will be published in the upcoming Value in Health Journal (December 2020 Issue, Volume 23 and Issue S2).
Boston Healthcare Presents Key Findings Associated With the Use of an AI-Enabled In Vitro Diagnostic Test
27 March 2020
The Boston Healthcare team presented key findings related to the health economic value associated with the use of an AI-enabled in vitro diagnostic test to identify CKD patients with type 2 diabetes at risk for rapid kidney function decline. BHA’s Senior Vice President, Thomas Goss, made a presentation during the late-breaker session at the National Kidney Foundation Spring Clinical Meeting in March 2020.
Read the article here: https://bit.ly/2UKaJks
View the poster here: https://bit.ly/2UFIx27
Diagnostics Developers Rapidly Utilizing New Payment Codes Established by PAMA
7 November 2018
Access the article from 360Dx here.
Clinical Omics
Compliance Conundrum: Genomic Health Faces DoJ Investigation after CMS Changes Date of Service Regs
Genomic Health has disclosed that it is the subject of a U.S. Department of Justice investigation into its compliance with changes that took effect in January to Medicare’s Date of Service billing regulation. Adam Crowther, Manager, spoke with Clinical Omics about the impact on diagnostics companies. Access the Article Here.
Medical Device & Diagnostics Industry
Considering Market Access Risk as Part of Today’s M&A Process
In an exclusive published today in Medical Device and Diagnostics Industry, Vice President, Rob Wenthold discusses the key market access issues examined during the M&A process and demonstrates the importance of market access to inform M&A through case studies and business decision-making in general. Read the article here.